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Tocilizumab Prefilled Syringe

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 5, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

Tocilizumab Prefilled Syringe · 1 trial · 2 indications

Phase 1 1
NCT04885829Comparative Study of 3 Tocilizumab Products in Normal Healthy VolunteeersRheumatoid Arthritis
COMPLETED300 Analytics
PHASE1COMPLETED
Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers
Rheumatoid Arthritis
NCT04885829300
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Study Endpoints

Primary Endpoints

To demonstrate the PK (Pharmacokinetics) similarity of DRL_TC vs RP, DRL_TC vs RMP and RP vs RMP.
Period I pre-dose (1hour prior to drug administration), Days 1, 2, 3, 4, 5, 6, 7, 9, 11, 15, 18, 22, 29, 36, 43 and Period II - Day 1 (dosing), 2 ,3 , 4 , 5 , 6, 7, 9, 11, 15, 18, 22, 29 , 36 , 43 (-2 to +4 days)

AUC0-∞ and AUC0-t will be calculated

To demonstrate the PK (Pharmacokinetics) similarity of DRL_TC vs RP, DRL_TC vs RMP
Period I pre-dose (1hour prior to drug administration), Days 1, 2, 3, 4, 5, 6, 7, 9, 11, 15, 18, 22, 29, 36, 43 and Period II - Day 1 (dosing), 2 ,3 , 4 , 5 , 6, 7, 9, 11, 15, 18, 22, 29 , 36 , 43 (-2 to +4 days)

Cmax will be calculated

Secondary Endpoints

Safety assessment
Screening (Days -28 to -2), Day -1, predose (within 1hour before dosing), post dose (10 minutes, 60 minutes, 4 hours, 8 hours, 12 hours on day 1 and 43) and 24hours, 36hours, 48hours, 60 hours, 72 hours and 84hours after dosing
IL-6 assessment
Period I - Day-1, 2, 5, 15 and Period II - Day -1 , 2 , 5 , 15
hsCRP assessment
Period I - Day-1, 2, 5, 15 and Period II - Day -1 , 2 , 5 , 15
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DRL_TCEXPERIMENTALSubcutaneous injection of DRL's Tocilizumab
RP and RMPACTIVE_COMPARATORSubcutaneous injection of Actemra and RoActemra (Commercially available Tocilizumab)

Interventions

NameTypeDescription
Tocilizumab Prefilled SyringeDRUG0.9ml Subcutaneous pre-filled syringes containing 162mg of Tocilizumab.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: 1. Healthy male and female volunteers, 18 to 50 years of age at the time of signing informed consent. 2. In general good health as determined by a qualified physician based on a comprehensive medical history, physical examination including vital signs, laboratory haematology, cl...

Countries:AustraliaIndiaNew Zealand
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Competitive Landscape -Rheumatoid Arthritis 92 trials

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV5PHASE3Adalimumab, Upadacitinib
Bristol-Myers Squibb CompanyBMY6PHASE3Abatacept, Adalimumab, Methotrexate
Eli Lilly and CompanyLLY4PHASE3Baricitinib, Tocilizumab
Johnson & JohnsonJNJ1PHASE3Guselkumab
AstraZeneca PLCAZN4PHASE2AZD1163
Novartis AG Sponsored ADRNVS3PHASE2VAY736 PFS, VAY736 AI
Merck & Co., Inc.MRK2PHASE2Tulisokibart, Methotrexate
AnaptysBio, Inc.ANAB1PHASE2Rosnilimab
Spyre Therapeutics, IncSYRE1PHASE2SPY002-072
Sanofi SA Sponsored ADRSNY2PHASE2Sarilumab SAR153191
Immunovant IncIMVT1PHASE2IMVT-1402
XBiotech, Inc.XBIT1PHASE2Natrunix, Methotrexate
Amgen Inc.AMGN1PHASE2Inebilizumab, Blinatumomab
Artiva Biotherapeutics, Inc.ARTV2PHASE2Allogeneic NK Cells
Gilead Sciences, Inc.GILD1PHASE1GS-0151
Zenas BioPharma, Inc.ZBIO1PHASE1ZB002
Stryker CorporationSYK5N/AUndisclosed
Zimmer Biomet Holdings, Inc.ZBH29N/AUndisclosed
Cullinan Therapeutics, Inc.CGEM1PHASE1CLN-978
Sonoma Pharmaceuticals, Inc.SNOA2PHASE1SBT777101
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Frequently asked questions about Tocilizumab Prefilled Syringe

What is Tocilizumab Prefilled Syringe used for?

Tocilizumab Prefilled Syringe is used for Rheumatoid Arthritis. It is being developed by Dr. Reddy's Laboratories Ltd as a small molecule therapy in the immunology therapeutic area. The drug is currently in Phase 1 clinical development.

Who makes Tocilizumab Prefilled Syringe?

Tocilizumab Prefilled Syringe is developed by Dr. Reddy's Laboratories Ltd, a company listed on the stock exchange under the ticker RDY. The drug is currently in Phase 1 clinical development for Rheumatoid Arthritis.

What phase is Tocilizumab Prefilled Syringe in?

Tocilizumab Prefilled Syringe is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for Rheumatoid Arthritis.

What clinical trials is Tocilizumab Prefilled Syringe in?

Tocilizumab Prefilled Syringe has one completed clinical trial, NCT04885829, titled 'Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteers'. This Phase 1 study enrolled 300 participants and was conducted in Australia, India, and New Zealand.

Is Tocilizumab Prefilled Syringe the same as tocilizumab?

Tocilizumab Prefilled Syringe is a formulation of tocilizumab, a drug used for Rheumatoid Arthritis. The prefilled syringe is a specific delivery form developed by Dr. Reddy's Laboratories Ltd. It is currently in Phase 1 clinical development.